Comparing blood-thinning treatments after heart valve replacement

Antithrombotic Strategy Based on Clinical Events and 4D-CT for Patients After TAVR

This study tests whether taking blood thinners or aspirin after heart valve replacement helps patients stay healthy and prevents blood clots.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 650 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: China National Center for Cardiovascular Diseases (Government)
• Locations: 1 site (Beijing, Beijing)
• Trial ID: NCT05375474 on ClinicalTrials.gov

What this trial studies

This multicenter, open-label, randomized controlled study aims to evaluate the effectiveness of oral anticoagulation therapy compared to single antiplatelet therapy in patients who have undergone transcatheter aortic valve replacement (TAVR). Participants will be randomly assigned to receive either vitamin-K antagonists or aspirin for six months, followed by aspirin for all patients for the remainder of the study. The study will monitor patients for one year to assess clinical outcomes and the incidence of bioprosthetic valve thrombosis using 4D-CT imaging.

Who should consider this trial

Good fit: Ideal candidates are patients aged 18-85 with severe aortic stenosis who have successfully undergone TAVR.

Not a fit: Patients with indications for anticoagulation therapy or those requiring double antiplatelet therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into the most effective antithrombotic strategy for patients after TAVR, potentially improving patient outcomes.

How similar studies have performed: Other studies have explored antithrombotic strategies in similar populations, but this specific approach is novel.

Eligibility criteria

Inclusion Criteria:

* Patients aged 18-85 years old with severe aortic stenosis;
* Successful TAVR via femoral artery approach (VARC 3 device success criteria);
* Implantation of self-expanding bioprosthetic valve;
* Be willing to give informed consent.

Exclusion Criteria:

* Patients with anticoagulant indications, such as atrial fibrillation, intracardiac thrombosis, deep vein thrombosis, pulmonary embolism, history of mechanical valve implantation;
* Patients needed double antiplatelet therapy, such as acute myocardial infarction within one year, coronary stent implantation within 6 months, peripheral artery stent implantation within 3 months;
* Patients who received concomitant TAVR and percutaneous coronary intervention;
* Patients with peptic ulcers or active bleeding or history of cerebral hemorrhage
* Patients with ischemic stroke or TIA within 6 months;
* Patients with left ventricular ejection fraction \< 30% or pulmonary hypertension (\>70mmHg) before discharge;
* Patients intolerant or allergic to aspirin or Vitamin-K antagonists (warfarin);
* Patients with evaluated glomerular filtration rate \<15ml/min/m2 (Cockcroft formula) or on dialysis;
* Patients with poor compliance, unable to complete the study and follow-up as required;
* Patients' life expectancy less than 1 year;
* Patients who already participated in other clinical trials (within the last 30 days).

Where this trial is running

Beijing, Beijing

• Fuwai hospital — Beijing, Beijing, China (Recruiting)

Study contacts

• Study coordinator: Yongjian Wu, MD,PhD

Conditions Transcatheter Aortic Valve Replacement; Antithrombotic Therapy; Bioprosthetic Valve Thrombosis